510(k) K093064

TUMARK PROFESSIONAL, MODEL 271560, MR-TUMARK PROFESSIONAL, MODEL 601560 by Somatex Medical Technologies GmbH — Product Code NEU

K093064 is an FDA 510(k) premarket notification submitted by Somatex Medical Technologies GmbH for the device "TUMARK PROFESSIONAL, MODEL 271560, MR-TUMARK PROFESSIONAL, MODEL 601560". The FDA issued a decision of Substantially Equivalent on February 17, 2010. The device falls under product code NEU (Marker, Radiographic, Implantable), a Class II device regulated under 21 CFR 878.4300. Somatex Medical Technologies GmbH has at least 6 other 510(k) clearances on record.